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K Number
K963737
Device Name
HYCEM APLICAP
Manufacturer
ESPE GMBH & CO. KG.
Date Cleared
1996-11-15

(59 days)

Product Code
EMA
Regulation Number
872.3275
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Hycem® Aplicap® is intended for final cementation of restorations composed of all classes of materials, including for cementation of crowns, bridges, inlays/onlays, pins and screws, and brackets and bands.

Device Description

compomer luting cement, tradenamed Hycem® Aplicap®

AI/ML Overview

This 510(k) summary for K963737 describes the Hycem® Aplicap® compomer luting cement. However, the provided text does not contain any information regarding clinical studies, acceptance criteria for device performance, or data related to AI/algorithm performance.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them, nor can I provide information on sample sizes, expert involvement, or ground truth, as none of this information is present in the provided document.

The document focuses on:

  • Intended Use: Final cementation of restorations (crowns, bridges, inlays/onlays, pins, screws, brackets, bands).
  • Substantial Equivalence Claim: To Dentsply Caulk's Advance™ Hybrid Ionomer Cement, based on similar intended use and composition.
  • Performance Claim: Hycem® Aplicap® meets the requirements of relevant DIN and ISO standards for dental cement. This is a general statement about physical properties, not specific clinical performance metrics.

To answer your questions accurately, a document detailing performance studies (clinical or benchtop with specific acceptance criteria) would be required.

§ 872.3275 Dental cement.

(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.